Enhanced therapeutic stimulus system and methods of use

ABSTRACT

The present invention relates to a therapeutic system and methods of using the therapeutic system. In particular, the present invention relates to systems having hardware, software, and appliance components for assessing and entraining a neuromuscular pattern or behavior in a patient. The methods include configuring the hardware and software systems to receive data from an orofacial stimulation appliance and to generate a precise therapeutic pulse profile that is actuated as a tactile stimulus. In one embodiment, the system and methods also include collecting data using the orofacial stimulation appliance and delivering the tactile stimulus via the orofacial stimulation appliance to entrain an organized neuromuscular pattern or behavior.

FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

The subject matter discussed in this patent application was funded inpart by United States Grant No. R01-DC003311 from the National Instituteof Health (NIH). The government may have certain rights to the subjectmatter discussed herein.

FIELD OF THE INVENTION

The invention relates generally to systems and methods for stimulating acentral pattern generator and a trigeminal nerve in a brain of a humansubject. Specifically, the present invention relates to stimulation thatinfluences brain response or brain development including repair of thebrain, control of respiration, control of a non-nutritive suck pattern,mastication, and combinations thereof.

BACKGROUND OF THE INVENTION

Premature birth places infants at increased risk for learningdisabilities, delayed development of speech, language and motor skills,and mortality. The premature infant often has difficulties withrespiration and feeding and therefore may remain in the hospital forprolonged periods of time. The non-nutritive suck (NNS) is a motorbehavior that can be observed and used to make inference about braindevelopment and organization in this young population.

Oral stimulation therapy is a common practice, in which feedingtherapists manually apply a stimulation using their fingertip. Manuallyapplying stimulation, however, has a number of drawbacks. One suchdrawback includes the variance in the amount of motion (amplitude) andrhythm (frequency) from therapist to therapist, or even by the sameindividual. As a result, extensive and costly training and experienceare required for a therapist to be proficient at providing manualstimulation and assessment.

In addition, manual stimulation is given essentially blind, as patientscan respond by producing a variety of undesirable motor actions,including but not limited to clenching the jaws, tongue compression,tongue thrusting, or other reactions that may be confused with desirableNNS events. As such, it can be difficult to determine if the manualstimulation is beneficial to the patient.

Therefore, a need exists for an automated system and method of using thesystem to assess a patient's natural NNS pattern and to provide preciseand beneficial tactile stimulus to correct and organize the patients NNSpattern.

SUMMARY OF THE INVENTION

The present invention relates to a system having hardware, software, andappliance components for assessing and entraining a behavior in apatient and methods of using the system. In particular, the systemrelates to the use of specific wave patterns that correspond to actionpatterns, such that the subject's brain is stimulated. The presentinvention stimulates the central pattern generator of a subjectresulting in a developmental response in the orofacial region. In oneaspect, the system is used for stimulating a central pattern generatorand a trigeminal nerve in a brain of a human subject. The stimulationinfluences brain response or development of the brain, including but notlimited to the repair of the brain, control of respiration, control of anon-nutritive suck pattern, mastication, and combinations thereof. Thesystem includes an orofacial stimulator appliance that, when actuated inresponse to a signal, generates a mechanical transfer of energy. Thetransfer of energy can stimulate the subject's brain. The energy istransferred in at least one burst sufficient to be recognized as atactile stimulus by the central pattern generator of the brain. Eachburst includes at least two square wave pulses of the same amplitude,with the pulse period increasing with each successive pulse to form adecelerating pulse train sequence. The pulses range in frequency betweenabout 1.5 Hz and about 5 Hz. The pulses are contacted with the subjectfor at least two minutes each day and at least twice a day for a minimumof five successive days. The use of a square wave is important.

In one aspect, the system of the present invention uses a bi-directionalsquare wave pattern as an input signal to a patient. For example, thesquare wave pattern may be applied to the patient where it is perceivedas an input or feedback signal which then functions as an artificialstimulator of a central pattern generator within the patient's brain.The square wave pattern therefore resonates with the neural system ofthe patient.

In another aspect, the system is used for stimulating a central patterngenerator and a trigeminal nerve in a brain of a subject. The subjectmay be an adult, an infant, a stroke patient, or other neurologicallydeficient patients. The stimulation influences brain response ordevelopment of the brain, including but not limited to the repair of thebrain, control of respiration, control of a non-nutritive suck pattern,mastication, and combinations thereof. The system includes a controlsystem for generating a pressure pulse signal using a pneumatic pulsegenerator assembly. Other systems may be used, but a pressure pulse hasbeen shown to be effective. The pneumatic pulse generator assembly canfurther include a linear motor mechanically engaged to a piston of apneumatic piston and cylinder assembly, wherein the linear motor exertsforce on the piston. The pneumatic piston and cylinder provides apneumatic pressure pulse to the pliable pacifier through a pneumaticairline in response to the force applied to the piston. The pressuretransducer assembly also includes at least one feedback sensor toprovide position feedback data and pressure feedback data of the linearmotor. Other systems may be used so long as generate a constant,precise, and modifiable pressure pulse to the subject's mouth and lips.

The system further includes, for example, an orofacial stimulatorappliance having the pacifier in fluid engagement with a receiver tube.The receiver tube is in fluid communication with the pneumatic airlineto provide the pneumatic pressure pulse from the pneumatic piston andcylinder to the pacifier surface. The orofacial stimulator appliancealso includes a removable receiver tube insert received in the receivertube to limit a total volume of air in receiver tube.

The pneumatic pulse generator assembly actuates the orofacial stimulatorappliance to generate a mechanical transfer of energy. The energy istransferred in at least one burst sufficient to be recognized as atactile stimulus recognized by the central pattern generator of thebrain. Each burst includes at least two square wave pulses of the sameamplitude, with the pulse period increasing with each successive pulseto form a decelerating pulse train sequence. The pulses range infrequency between about 1.5 Hz and about 5 Hz. At least six successivebursts are contacted with the subject for at least two minutes, at leasttwice daily.

In various aspects, the orofacial stimulator appliance further includesa pneumatic pulse generator having a PID controller and a pump. Theorofacial stimulator appliance may also include a piezoelectric system.The orofacial stimulator appliance may also be in communication with acontrol application executable at a processor. The processor may be apart of a computing device further having a display device and an inputdevice.

The orofacial stimulator applicator may further include a handpiece, areceiver tube, a receiver tube insert, and a pacifier or baglet. Inaddition, the handpiece may include a push-button switch incommunication with the control application.

The PID controller may be a real-time industrial controller, such as aCompactRIO controller. The pump is a linear motor that may furtherinclude a position feedback sensor and a pressure feedback sensor. Inaddition, the pneumatic pulse generator may be a pneumatic piston andcylinder.

In one aspect, each of the two or more pressure pulses includes a dampedharmonic of a base frequency. The damped harmonic for the two or morepressure pulses may be identical or vary in frequency. For example, thetwo or more pressure pulses may have a damped harmonic oscillatorprofile having a Q factor greater than or equal to ½.

The system may be used to perform various methods for stimulating acentral pattern generator and a trigeminal nerve in a human brain of asubject. The stimulation influences brain response or development of thebrain, including but not limited to the repair of the brain, control ofrespiration, control of a non-nutritive suck pattern, mastication, andcombinations thereof. The method includes the steps of contacting thehuman subject with an appliance to stimulate one or more nerve endingsnear the subject's mouth, including the facial region proximal to atleast one lip and a tongue. The method also includes the steps ofactuating the appliance in response to a signal to generate a mechanicaltransfer of energy. The energy is transferred in at least one burstsufficient to be recognized as a tactile stimulus by the central patterngenerator of the brain. Each burst includes at least two square wavepulses of the same amplitude, with the pulse period increasing with eachsuccessive pulse to form a decelerating pulse train sequence. The pulsesrange in frequency between about 1.5 Hz and about 5 Hz.

In various aspects, six bursts of the pulses are contacted with thesubject for at least two minutes each day and at least twice a day for aminimum of five successive days. In addition, the square wave pulse maydisplace a surface of the appliance between about 150 microns and 300microns or between 260 microns and 300 microns for between about 20milliseconds and about 50 milliseconds.

In one aspect, the pulses in the burst decelerate. For example, thedecelerating pulse train may have period intervals of 510, 526, 551,580, and 626 ms. Similarly, the pulse spectra may have frequencies of1.7 Hz, 5.5 Hz, 9.0 Hz, 12.5 Hz, and 16.5 Hz.

The method may also include the steps of stimulating an olfactory orauditory region of the brain. The method may also include generating orprojecting sound waves to generate the square wave pulses. Typically,the tactile stimuli provided by the method are above any backgroundactivity of the subject and the signal to generate the mechanicaltransfer of energy is a high velocity signal. In various aspects, themethod may be formed on infants with a heart defect or on strokepatients. Related objects and advantages of the present invention willbe apparent from the following description.

DESCRIPTION OF FIGURES

FIG. 1 is a block diagram of a therapeutic stimulus system according toone aspect.

FIG. 2 is a block diagram of computing environment according to oneaspect of the therapeutic stimulus system.

FIG. 3 is a block diagram of data source according to one aspect of thetherapeutic stimulus system.

FIG. 4 is a block diagram of a non-nutritive suck entrainmentapplication according to one aspect of the therapeutic stimulus system.

FIG. 5 is a block diagram of a system module according to one aspect ofthe therapeutic stimulus system.

FIG. 6 is a block diagram of an assessment module according to oneaspect of the therapeutic stimulus system.

FIG. 7 is a block diagram of a therapy module according to one aspect ofthe therapeutic stimulus system.

FIG. 8A is a block diagram of a therapeutic pulse generation systemaccording to one aspect of the therapeutic stimulus system.

FIG. 8B is a block diagram of an orofacial stimulator applianceaccording to one aspect of the therapeutic stimulus system.

FIG. 9 is a block diagram of a therapeutic stimulus system according toone aspect.

FIG. 10A is a graph depicting the displacement of pacifier in responseto a therapeutic pressure pulse sequence according to one aspect.

FIG. 10B is a graph depicting the change in the mean diameter of apacifier in response to a pressure pulse according to one aspect.

FIG. 10C is a graph depicting a therapeutic burst according to oneaspect.

FIG. 10D is a graph depicting a square wave pulse according to oneaspect.

FIG. 10E is a graph depicting a power spectrum of a square wave pulseaccording to one aspect.

FIGS. 10F-I depict the results of analysis comparing the effects ofvarious pulses as they relate to orofacial behaviors.

FIG. 11A illustrates a method for assessing a non-nutritive suck patternaccording to one aspect of the therapeutic stimulus system.

FIG. 11B illustrates a method for stimulating a patient to entrain anorganized non-nutritive suck pattern according to one aspect of thetherapeutic stimulus system.

FIGS. 12-31 are screenshots of various graphic user interface displaysaccording to aspects of the therapeutic stimulus system.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to a system for assessing and the neuralentrainment of a patient. In one aspect, the patient may be a prematureinfant; however, the system may also be used for patients unable toproperly suck or swallow to receive nourishment, including but notlimited to full-term infants, toddlers, adolescents, and adults. Forexample, the system may be used to treat those that have beendebilitated by strokes, hemorrhages, heart defects, or other conditionsthat correlate with an impairment in neurological development orfunction.

In one aspect, the system of the present invention uses a bi-directionalsquare wave pattern as an input signal to a patient. For example, thesquare wave pattern may be applied to the patient where it is perceivedas an input or feedback signal which then functions as an artificialstimulator of a central pattern generator within the patient's brain.The square wave pattern therefore resonates with the neural system ofthe patient.

The non-nutritive suck (NNS) pattern of a patient is generated by thepatient's suck central pattern generator (sCPG). A central patterngenerator (CPGs) is a neural circuit or combination of neural circuitslocated in the patient's cerebral cortex, brainstem, and/or spinal cordthat drives rhythmic motor behaviors such as sucking, breathing,mastication, and locomotion. The patterns generated by the CPGs can bemodulated by a variety of external stimuli, such as the square wavepattern of the present invention. In particular, the square wave patternmay be applied to the mouth and lips of a patient where the tonguefunctions as a high-pass filter to permit components of the square wavepattern matching a natural oscillation pattern of the sCPG to stimulatethe patient's sCPG. As such, the most beneficial therapeutic results aremanifested when the therapy consistently mimics the intrinsic frequencyof sCPG.

It is often difficult for therapists to model the fine temporalstructure of an organized NNS burst pattern, which involves afrequency-modulated (FM) burst structure, using manual stimulation. TheFM burst structure is characterized by a series of suck cycles thatsuccessively decrease in frequency from the first compression cycle ofthe lips and mouth to the last compression cycle. The FM burst structuretypically modulates between 1.5 Hz and 3 Hz. The structure of the FMburst is very difficult if not impossible to produce manually in arepeated pattern by even the most experienced therapist.

The present invention relates to the identification of particularcharacteristics of the FM burst structure and provides criteria ordescriptions of features of the NNS pattern that may be used asdiagnostic indicators for gauging the development of oromotor controlamong patients. Further, the identified characteristics may be useful inconfiguring a tactile stimulus that may be applied to patients to modifyor correct a deficient NNS pattern.

The Therapeutic Stimulus System

FIG. 1 is a block diagram of a therapeutic stimulus system 100 forassessing a patient's neuromuscular behavior and for providing a tactilestimulus that will stimulate a central pattern generator (CPG) andtrigeminal nerve of a human brain to entrain a desired neuromuscularpattern. The therapeutic stimulus system 100 may be used to assess andentrain brain activity for controlling respiration, mastication, otherneuromuscular functions, or combinations thereof. For example, thetherapeutic stimulus system 100 may be used to treat patients sufferinga stroke or other conditions that prevent the patient from performing adesired function. The therapeutic stimulus system 100 includes acomputing device 102 to process data and execute one or moreapplications, a data source 104 to store data, a pulse generation system106 to generate pneumatic pulses in response to input signals, and anorofacial stimulator appliance 108 to transfer the pneumatic pulses to apatient as a tactile stimulus.

According to one aspect, the therapeutic stimulus system 100 can be usedfor assessing a patient's natural non-nutritive suck (NNS) pattern andfor providing a tactile stimulus that will stimulate the suck centralpattern generator (sCPG) and trigeminal nerve of the patient's brain toentrain a proper NNS pattern.

By way of example and not limitation, the computing device 102 mayinclude memory 200 and at least one processor 202 to execute a NNSassessment and therapy application (NNS application) 204, as shown inFIG. 2. The computing device 102 also includes a display 206, such as acomputer monitor, for displaying data stored in the data source 104,data received from the pulse generation system 106 or the orofacialstimulator appliance 108, and data input by a user of the therapeuticstimulus system 100. The display device 206 also displays one or moregraphical user interfaces (GUIs) input forms or displays, generated bythe NNS application 204, as shown in FIGS. 12-31. The GUI input formsand displays enable a user of the therapeutic stimulus system 100 toinput, view, and/or interact with the various modules of the system. TheGUI input forms and displays also allow a user to input, view, and/orinteract with patient data, NNS assessment data, NNS therapy data,and/or other data related to the assessment and therapeutic stimulationof the patient. Further, the GUI input forms and displays permit a userto configure and interact with the pulse generation system 106 and theorofacial stimulator appliance 108.

The computing device 102 may also include an input device 208, such as akeyboard or a pointing device (e.g., a mouse, trackball, pen, or touchscreen) to enter data or configure a feature of the therapeutic stimulussystem 100 using the GUI input forms and displays. The computing device102 may further include, or at least be in communication with, the datasource 104.

The data source 104 may be a database stored on a local hard disk drive(HDD) incorporated into the computing device 102. Alternately, the datasource 104 may be a database or other data structure stored remotelyfrom the computing device 102. For example, the computing device 102 maybe in communication with the data source 104 over a network, includingbut not limited to the Internet. As shown in FIG. 7, the data source maystore a variety of data. For example, the data source 104 may store userdata 700 that includes profiles and login information, such aspasswords, for users of the therapeutic stimulus system 100. The datasource 104 may also contain patient data 702 including patient chartsand historical assessment and therapy session data 704 and 706,respectively. The data source 104 also stores data for therapy protocolsor therapy pulse profiles 708 that may be used to entrain a variety ofpatients, as well as, other data 710 gathered from experiments orresearch trials conducted using the therapeutic stimulus system 100.

According to one aspect, as shown in FIG. 3, the NNS assessment andtherapy application 204 includes a number of instructions, applets,modules 300-308, and submodules to receive, process, and generate dataand/or signals for the assessment of a NNS pattern and the therapeuticstimulation of a patient's mouth and lips to entrain a proper NNSpattern. The modules of the NNS assessment and therapy application 204include an NNS system module 300, an assessment module 302, a therapymodule 304, a leak detection module 306, and a research module 308.

The NNS system module 300 includes various submodules 400-406 to provideaccess to various the features and functionality of the NNS assessmentand therapy application 204. For example, the NNS system module 300includes a user login submodule 400 that allows a user of thetherapeutic stimulus system 100 to login into the NNS application 204.In one aspect, the NNS system module 300 generates GUI input forms 1200and 1202, as shown in FIGS. 12-13, where the user may select a useraccount and log in to the NNS application 204 after entering a validpassword for the selected user.

The NNS system module 300 includes a user configuration submodule 402that allows users of the therapeutic stimulus system 100 with sufficientprivileges to add, edit, or delete user accounts. By way of example andnot limitation, an administrator may input data into GUI input forms1204 and 1206, as shown in FIGS. 14-15 to create, modify, or delete auser profile to grant or restrict access to the NNS application 204.

Similarly, the NNS system module 300 includes a patient configurationsubmodule 404 that allows users of the therapeutic stimulus system 100with sufficient privileges to add, edit, or delete patients. By way ofexample and not limitation, an administrator may input data into inputforms 1208 and 1210, as shown in FIGS. 16-17, to create, modify, ordelete a profile for a patient that may receive an NNS assessment ortherapy using the therapeutic stimulus system 100. The NNS system module300 also includes a session selection submodule 406 that allows users ofthe therapeutic stimulus system 100 to select whether the NNS systemwill be used to assess a patient's naturally generated NNS pattern or toprovide therapeutic stimulus to the patient. As such, the sessionselection submodule 406 sends requests to the assessment module 302 andthe therapy module 404 in response to type of session selected by theuser.

When an assessment request is generated, the NNS system module 300generates a main assessment input form 1212 to allow the user to inputdata and interact with the NNS application 204 during the assessmentsession. By way of example, and not limitation, an embodiment of themain assessment input form 1212 is shown in FIG. 18. In one aspect, themain assessment input form 1212 includes one or more control buttons1214 to access a list of all the patients actively associated with theNNS application 204. When a patient is selected, the main assessmentinput form 1212 displays a history 1216 of assessments for the selectedpatient, and is capable of displaying waveforms from the previousassessments in a waveform frame 1218. In one aspect, the prior waveformsand assessment histories 1216 may be stored as assessment session data704 in the data source 104.

The main assessment input form 1212 also includes a control button 1220to permit a user to view a patient's medical chart 1294, an example ofwhich is shown in FIG. 31. In addition, the control button 1220 allowsthe user to add or edit patient data, while control button 1222 allowsthe user to add notes to the patient assessment data. In addition, theuser may select control button 1224 to start a new assessment sessionfor the selected patient or select control button 1226 to switchdirectly to a therapy session for the selected patient.

In one aspect, the assessment module 302 includes a number of submodules500-508, including but not limited to an assessment configurationsubmodule 500, an assessment calibration submodule 502, an assessmentcapture module 504, a feature extraction submodule 506, and apost-assessment review module 508. The various submodules 500-508generate and display one or more GUI input forms as shown in FIGS. 19-26that allow the user to configure, initiate, and review an assessmentsession.

The assessment configuration submodule 500, for example, generates anassessment configuration GUI input form 1228. The assessmentconfiguration GUI input form 1228 includes one or more controls1230-1242 and data fields 1244-1248 to input data for selecting orconfiguring an assessment session. The input data may relate to a totalassessment time 1246, an intermediate assessment prompt 1244, a type andconfiguration 1236 of a baglet or pacifier 810, and optionally, thepatient's weight 1248. As the behavior and mood of a patient is oftenunpredictable, it is difficult for the user to know in advance how longthe assessment session may take. Therefore, the intermediate assessmentprompt is selected as a ‘best estimate’ for the actual time that it maytake to capture enough NNS pattern activity to assess the patient. Assuch, the total assessment time permits the user to continue to collectdata, if desired, after the intermediate assessment prompt. In oneaspect, the assessment collection submodule 504 halts the capture ofassessment data at the intermediate assessment prompt.

The assessment calibration submodule 502 generates an assessmentcalibration GUI input form 1250. In one aspect, the calibration inputform 1250 allows the user to communicate with and configure the pulsegeneration system 106 and the orofacial stimulator appliance 108 toverify the intended function and calibration for the components of thepulse generation system and the orofacial stimulator appliance prior tothe initiation of an assessment session.

The assessment capture submodule 504 receives the digital pressuresignal from the pulse generation system 106. In one aspect, theassessment capture submodule 504 records and displays the patient's NNSpattern activity as a waveform 1252. In other aspects, the assessmentcapture submodule 504 may receive and store the digital pressure signalwithout displaying the NNS pattern activity. In another aspect, theassessment capture submodule 504 may display the NNS pattern activity inanother form, such as a chart, graph, or table.

The assessment capture submodule 504 may further generate a number ofdisplays during the assessment capture session. For example, FIGS. 22-25are screen displays that show the progress of the assessment session atthe start of the session 1254, at the intermediate prompt interval 1256,at the user input duration time 1258, and at the conclusion of theassessment session 1260. In other aspects, fewer or a greater number ofdisplays 1254-1260 may be provided during the assessment session.

In one aspect, the assessment data capture session may be initiated byinput received through a start control button 1262 shown on the display206. Alternately, the assessment data capture session may be initiatedby a switch on a handpiece 806 of the orofacial stimulator appliance108.

During or subsequent to an assessment session, the feature extractionsubmodule 506 analyzes the digital pressure signal received by theassessment capture submodule 504. In particular, the feature extractionsubmodule 506 identifies various components of the patient's generatedNNS pattern. For example, in the waveform 1252 of FIG. 21, the featureextraction submodule 506 identifies pressure peaks 1264, individual suckevents 1266, as well as bursts 1268, which are defined as two or moresuck events in less than about 1.2 seconds. In addition, the featureextraction submodule 506 also identifies a number of non-NNS events1270, such as chewing motions made by the patient. In one aspect, thefeature extraction submodule 506 may provide annotations, includingcolor-coding, to identify the various NNS events 1264-1268.

In one aspect, the feature extraction submodule 506 quantifies theoverall performance of the patient's generated NNS pattern by assigninga Spatiotemporal Index (STI) value to the pattern. For example, the STIvalue may be derived by calculating the similarity of up to fiveindividual suck bursts. The STI value measures the symmetrical andrepetition of the patient's generated NNS burst pattern by integratingthe symmetry and quantity of selected NNS events 1264-1268 in thepatient's NNS pattern.

In another aspect, the feature extraction submodule 506 automaticallydetermines a number of parameters that are desirable for evaluating thepatient's generated NNS pattern and determining the best course oftherapy to treat the patient. For example, the evaluation parameters mayinclude the STI value for the waveform, the number of bursts per minute,the number of events per burst, the number of NNS events per minute, anaverage peak pressure, as well as the total number of events per minute.In other examples, a fewer or greater number of parameters as well asdifferent parameters may be considered when evaluating the patient'sgenerated NNS pattern.

The evaluation parameters may be determined using a portion or subset ofthe collected assessment data. For example, a “most active” two-minutewindow having the most number of NNS events is identified by the featureextraction submodule 506. The most-active window is generally indicatedby a bar 1272 on the displayed waveform 1252. When calculating the sixevaluation parameters, the feature extraction submodule 506 may ignoreany NNS activity outside of the most-active window.

After capturing the patient's generated NNS pattern and determining theevaluation parameters, the post assessment review module 508 generates apost-session GUI input form 1274 where the user may confirm the identityof the patient that underwent the assessment session and input notesregarding the assessment session. By way of example and not limitation,the user may indicate the state of alertness for the patient, byinputting terms such as alert, crying, drowsy, sleepy, or any other termthat identifies the patient's level of alertness during the assessmentsession. The user may further quantify the patient's state of alertnessas active or quiet, as the patient's STI value may fluctuate betweenassessment sessions due to the patient drifting off to sleep during thecapture period.

Once a patient has been diagnosed or characterized as having adisorganized NNS pattern, it is often desirable for the patient toundergo a therapy session to entrain the patient's sCPG to produce anorganized NNS pattern. Typically, a therapy session consists of applyingan external stimulus to or near the lips and mouth of the patient inorder to modify the NNS pattern generated by the sCPG. The orofacialstimulator appliance 108 contacts the patient on or near the lips andmouth to deliver therapeutic stimulation, provided by the pacifier'smotion as caused by the pressure pulses, to the patient's orofacialnerves via regulated changes in the surface diameter of a pacifier 810that is a component of the orofacial stimulator appliance 104, as shownin FIGS. 8B and 9. The pressure pulses conveyed by the orofacialstimulator appliance 108 are actuated at the pulse generator or pulsetransducer system 104 in response to a therapy pulse profile generatedby the therapy module 304.

When a therapy session is to be performed, the NNS system module 300generates a main therapy GUI input form 1276, as shown in FIG. 27. Themain therapy GUI input form 1276 includes a control button 1278 to allowa user to start new therapy session. The main therapy GUI input form1276 also includes a control button to display previous therapy sessiondata 706 stored in the data source 104, the therapy sessions data 706includes summaries and detailed information for previous therapysessions.

In one aspect, the therapy module 304 includes a number of submodules600-606, including but not limited to a therapy configuration submodule600, a therapy calibration submodule 602, a therapy execution submodule604, and a post-therapy review submodule 606. The various submodules600-606 generate one or more GUI input forms for display that allow theuser to configure, execute, and review a therapy session.

The therapy configuration submodule 600, for example, generates atherapy configuration input form 1280. The assessment configuration GUIinput form 1280 includes a number controls 1282-1286 related to thetherapy session and the pacifier 810 of the orofacial stimulatorappliance 108. The assessment configuration GUI input form 1280 alsoincludes a control button 1288 that allows the user to select or modifyone or more therapy pulse profiles.

A therapy pulse profile consists of one or more therapeutic waveformsthat result in variable but controlled radial displacements of the outersurface of the pacifier 810. The surface displacements of the pacifier810 provide a tactile stimulus to or near the lips and mouth (e.g.,intraoral, anterior tongue tip, anterior tongue dorsum) of the patientto entrain the patient's sCPG to naturally produce an NNS pattern thatmimics the generated therapy waveforms. Once configured, the therapywaveforms are actuated by the pulse generation system 106, as shown inFIGS. 8A and 9.

The therapy calibration submodule 604 functions similar to theassessment calibration submodule 502 and generates a therapy calibrationGUI input form similar to the assessment calibration GUI input form1250. In one aspect, the calibration GUI input form allows the user tocommunicate with and configure the pulse generation system 106 and theorofacial stimulator appliance 108 to verify the intended function andcalibration of the instruments prior to the start of the therapysession.

The therapy execution submodule 604 captures and displays the patient'sNNS pattern activity during a therapy session. The therapy executionsubmodule 604 may generate a display 1290, as shown in FIG. 29, thatshows progress of the therapy session at the start of the session,during the therapy session, at a rest interval, and at the conclusion ofthe therapy session, respectively. In other aspects, fewer or a greaternumber of displays may be provided during the therapy session.

Similar to an assessment session, the therapy session may be initiatedby input received through the start control button 1278 of the GUI inputform 1276. Alternately, the therapy session may be initiated by a switch816 on a handpiece 806 of the orofacial stimulator appliance 108. Theswitch 816 may be any suitable switch including, but not limited to apush-button switch or a toggle switch. Further, the switch 816 may beused to alternate between a therapy mode and an assessment mode and/orto activate the therapy mode or assessment mode.

After a therapy session, the post-therapy review submodule 606 generatesa post-session GUI input form similar to the assessment post session GUIinput form 1274 where the user inputs notes regarding the therapysession. The user may indicate the state of alertness for the patient,such as alert, crying, drowsy, or sleepy.

The NNS application 204 further includes a leak detection module 306.The leak detection module 306 continuously monitors the performance ofpneumatic subsystems within the pulse generator system 104 and thepneumatic lines and connections of the orofacial stimulator appliance108 to detect air leaks.

In one aspect, the leak detection module 306 determines that there maybe an air leak by identifying reduced pulse amplitudes, increased pulseroll-offs, and/or the need for a greater stroke length in the pneumaticpulse generator 804 to generate the requested pressure. Further, theleak detection module 306 can identify air leaks caused by disconnectedairlines, and poorly seated receiver tubes or pacifiers. The module 306will display a warning 1292, as shown in FIG. 30, requiring the user toaddress the leak. The leak detection module 306 may monitor thetherapeutic stimulus system 100 automatically and continuously duringboth assessment and therapy sessions.

The NNS application 204 also includes the research module 308 thatallows a user of therapeutic stimulus system 100 to conduct variousresearch experiments and protocols. In particular, the research module308 receives and transmits data to an input/output (I/O) port of thecomputing device 102 or the real-time controller 800 of the pulsegeneration system 106. The I/O port, in turn, may be in communicationwith any of a variety of external instruments for conducting research.

In various other aspects, the NNS application 204 may include additionalmodules for other functions, including those typically associated withmedical or rehabilitation facilities. By way of example and notlimitation, the NNS application 204 may also include a billing module tointerface with an existing billing system or a printing module forprinting various data, charts, or reports.

The NNS Therapeutic Appliance Assembly

Referring now to FIGS. 1, 8A-B, and 9, the NNS Therapeutic applianceassembly includes the pulse generation system 106 and the orofacialstimulator appliance 108.

During an assessment session, the computing device 102 may record anddisplay a signal received from a pressure transducer 808 of theorofacial stimulator appliance 108, as shown in FIG. 8B. The transducer808 translates pressure changes caused by sucking and mouthing movementsof the patient into an analog signal that tracks the pressure applied toa pacifier 810 versus time. The analog pressure signal is converted to adigital signal at an analog-to-digital convertor 802 of the pulsegeneration system 106, as shown in FIG. 8A. The analog-to-digitalconverter 802 is incorporated into a real-time controller 800, thatreceives and modifies received and/or generated pressure signals inreal-time. The digital pressure signal is then received, recorded, anddisplayed by the assessment module 302.

Similarly, in one aspect of a therapy session, the pulse generationsystem 106 receives amplitude data 900 and pulse duration data 902 forthe desired waveforms. The amplitude data 900 and the pulse durationdata are provided to the real-time controller 800 which may include anH-bridge (not shown) and a proportional—integral—derivative controller(PID controller) 904. By way of example and not limitation, the PIDcontroller 904 may be a CompactRIO controller. The PID controller 904generates a signal 906 that is fed through a pulse-width modulation(PWM) component 908. The modulated signal 910 is then provided to amotor 912 of the pneumatic pulse generator 804. In one embodiment, thepneumatic pulse generator 804 consists of a linear motor 912mechanically engaged to an air cylinder, such as but not limited to anAirpel® airpot or other device having a piston fitted in a precisionbore cylinder with position and pressure feedback sensors incommunication with the PID controller 904. The pulse generator 804 alsoincludes a position feedback sensor 916 to monitor the position of thepiston of the dashpot 914 and a pressure feedback sensor 918 to monitorthe pressure with the dashpot 914. The air displaced by the pneumaticpulse generator 804 is then transmitted to the handpiece 806, throughone or more pneumatic airlines, where the therapy waveform displaces theouter surface of the pacifier 810. The pulse generator 804 may alsoinclude a vent valve 920 that is normally closed, however the valve maybe opened and vented to atmosphere to ensure pressure equilibrium at thestart of each assessment or therapy session. Optionally, the pulsegenerator 804 may also include another valve (not shown) that isolatesthe dashpot 914 from the handpiece 806 during a Power-On Self Test(POST). The optional valve therefore permits diagnostic testing of thetherapeutic stimulus system 100.

The orofacial stimulator appliance 108 includes the handpiece 806 andthe pacifier 810 that are brought into contact with the patient todeliver the therapeutic stimuli. In one aspect, the handpiece 806includes a receiver tube 812 in fluid communication with the interior ofthe baglet or pacifier 810. The receiver tube 812 includes an interiorvoid for receiving a volume of air from the pneumatic pulse generator804 or from the pacifier 810. Optionally, the handpiece 806 alsoincludes a receiver tube insert 814, that may be inserted in to thereceiver tube 812 to limit the total volume of air in the interior voidof receiver tube. The handpiece 806 may also include a mode valve 922that is opened or closed depending on whether an assessment session or atherapy session is to be performed.

In other aspects, the orofacial stimulator appliance 108 may include apiezoelectric system for generating an electrical charge in response toa mechanical stress or generating a mechanical stress in response to anelectrical charge. Further, the orofacial stimulator appliance 108 mayproduce or at least project sound waves to deliver the therapeuticstimuli. For example, the orofacial stimulator appliance 108 may includea speaker or other electroacoustic transducer (not shown) to projectsonic waves that stimulate the patient. The signals 906 and 910 or asignal to generate the sonic wave may be high-velocity signals.Preferably, the stimulus provided by the displacement of the outersurface of the pacifier 810 is recognized above and beyond anybackground activity or noise of the patient or the therapeutic stimulussystem 100.

In one aspect, the expansion characteristics of the therapy pulses asdelivered by expansion of the pacifier are verified using a lasermicrometer (not shown). The data from the laser micrometer regarding thefrequency and amplitude components of the therapy pulse at the pacifier810 may be digitized, recorded, and analyzed by the NNS application 204.

Preferably, the pacifier 810 is a Soothie NICU® pacifier or a WeeSoothie® pacifier; however, the size, shape, and/or type of pacifier 810may vary between procedures and/or patients. In addition, one or both ofthe pulse generation system 106 and the orofacial stimulator appliance108 may be configured for each particular patient.

The Therapeutic Waveform

Preferably, the therapy waveform consists of one or more salienttherapeutic bursts and each burst contains two or more square wavepulses. Typically, the bursts are separated by a configurable andvariable delay interval. FIGS. 10A and 10B depict plots 924 and 926 thatindicate changes in the pacifier 810 in response to a sequence of thetherapy waveforms.

According to one aspect, the nominal number of pulses in a desiredtherapeutic burst is six, while the actual number is configurable byusers of the therapeutic stimulus system 100. Preferably, each pulse ina therapeutic burst is a square wave pulse having the same configurableamplitude. Further, the period of each pulse increases sequentiallythereby, causing the waveform frequency to slow down from the start ofthe therapeutic burst to the end of the therapeutic burst. A desirabledecelerating sequence pulse sequence has periods of approximately 510±3ms, 526±3 ms, 551±3 ms, 580±3 ms, and 626±3 ms between therapeuticbursts. When more than five pulses are used in the therapeutic burst,the sixth and all subsequent pulses have an periodic interval ofapproximately 626 ms.

Preferably, each square wave pulse period is shaped to minimize thepositive and negative rise/fall times. For example, the transitionintervals of each pulse's leading or trailing edges between each pulsemay be tuned to create harmonics of 1.7±0.5 Hz, 5.5±0.5 Hz, 9.0±0.5 Hz,12.5±0.5 Hz, and 16.5±0.5 Hz. It is desired that the therapy waveformhave minimal ringing or flutter at the square wave peaks, in order to beperceived as a “clean” square waves. As the therapy pulse profiles maybe modified in the amplitude and frequency domains, a power spectrumanalysis shows that the preferred therapy waveform generatesdisplacement of the pacifier 810 at a fundamental frequency ofapproximately 1.7 Hz and higher orders. This fundamental frequency ispreferred to entrain the patient's nervous system through cutaneoussignal detection. Further, the preferred therapy waveform has a Q factorgreater than or equal to 1/2. As such, the relative high frequency ofthe rising and falling edges of the therapy pulse helps to achievestimulus salience in the patient. During a therapy session, the surfaceof the pacifier 810 may experience one or more positive displacements,one or more negative displacements, or combinations thereof, includingbut not limited to alternating between positive and negativedisplacements. A therapeutic burst 928 having square wave pulses tocause only positive displacement of a pacifier surface is shown in FIG.10C. Similarly, FIG. 10D depicts a single square wave pulse 930 having arapid rise time, indicated generally as 934, of approximately 0.017 ms.The rapid rise times of the square wave pulse, which is typically lessthan about 190 ms and particularly those less than about 50 ms, aresignificantly more effective than low-velocity stimulus patterns havingrise/fall times of approximately 190 ms or greater in providing patientswith a beneficial and salient neurotherapy.

In all aspects, the number of square wave pulses per therapeutic burst,the number of therapeutic bursts per therapy session, and the amplitudeof the square wave pulses are configurable by the user to account forvariability in the patients. For example, the age, endurance, and/oraptitude of the patients may vary, thereby requiring the user to selector modify a therapy pulse profile via the therapy configurationsubmodule 600.

By way of example and not limitation, FIG. 10E depicts a power spectrum934 of one exemplary square wave pulse. As shown, a fundamentalfrequency of approximately 1.709 Hz is generally indicated as 936. Incontrast to lower velocity pulses, the square wave pulse includesseveral harmonics, generally indicated as 938-942, that transfer energyat approximately 4.883, 5.615, and 9.277 Hz, respectively. Theadditional high frequency components 938-942 present in the square wavepulse contribute significantly to its tactile signature as a highervelocity signal.

FIGS. 10F-I illustrate the adjusted means and standard errors resultingfrom a multivariate statistical analysis that compared the effectivenessof the high-velocity pulse (HVP) versus a low-velocity pulse (LVP) asthey relate to four orofacial behaviors. FIGS. 10F-I depict the combinedadjusted means for a control group, a group exposed to LVPs (LVP group),and a grouped exposed to HVPs (HVP group). Each of the groups used inthe analysis were composed of four clinical sub-groups of preterminfants, including healthy infants, infants having respiratory distresssyndrome, infants having chronic lung disease, and infants with diabeticmothers.

In particular, FIG. 10F, illustrates that the HVP group, as indicated by944, generated a greater number of NNS Bursts per minute than thecontrol group, as indicated by 946, and the LVP group, as indicated by948. Similarly, FIG. 10G illustrates that the HVP group, as indicated by950, generated a greater number of NNS Cycles per minute than thecontrol group, as indicated by 952, or the LVP group, as indicated by954. FIG. 10H illustrates that the HVP group, as indicated by 956,generated a greater number of oral compression events per minute thanthe control group, as indicated by 958, or the LVP group, as indicatedby 960. Likewise, FIG. 10I illustrates that the HVP group, as indicatedby 962, generated a higher absolute percentage of NNS events relative tothe total oral compressions per minute than the control group, asindicated by 964, or the LVP group, as indicated by 966. As shown, theHVP group exceeded the control group and the LVP group, thus indicatingthat the HVP is providing a greater neurotherapeutic benefit to thecollective group of preterm infants. Further, within each HVP group, theinfants having respiratory distress syndrome, infants having chroniclung disease, and infants with diabetic mothers benefited more from theHVP stimulus than did the healthy infants.

Methods of Using the Non-Nutritive Suck Entrainment System (EntrainmentSystem)

FIG. 11A illustrates a method for performing an assessment session tocapture and analyze a patient's NNS pattern in accordance with an aspectof the therapeutic stimulus system 100. At step 1000, a user of thetherapeutic stimulus system 100 selects a patient from a displayed listof patients. The user then selects a control button to enter theassessment mode of the NNS application 204 at step 1002 and selects the“start new assessment” control button 1224 at step 1004. The assessmentsession is configured as desired at step 1006 based upon the patient'sage, injury, or other patient data 702 and optionally, data 704regarding the patient's assessment history. The orofacial stimulatorappliance 108 is calibrated at step 1008, while the patient ispositioned to encourage a rooting response to the orofacial stimulatorappliance at step 1010. At step 1012, the assessment session is started,while the orofacial stimulator appliance is contacted with the patient'slips and mouth at step 1014. In other aspects, the orofacial stimulatorappliance 108 is inserted into the patient's mouth at step 1014.Similarly, in other aspects, the steps 1012 and 1014 may be reversed.

Once the assessment session is completed, the orofacial stimulatorappliance 108 is removed from the patient at step 1016. After thefeature extraction submodule 406 analyzes the collected assessment data,using the input form 1274 generated by the post-assessment review module508. After the assessment session, the user may initiate anotherassessment session for the same patient or a different patient.Alternatively, the user may instead exit the NNS application 204.

FIG. 11B illustrates a method for performing a therapy session toentrain a patient's sCPG to generate an organized NNS pattern inaccordance with an aspect of the therapeutic stimulus system 100. Atstep 1110, a user of the therapeutic stimulus system 100 selects apatient from a list of patients. The user then selects a control buttonto enter the therapy mode of the NNS application 204 at step 1102 andthe selects a “start new therapy” control button 1278 at step 1104. Thetherapy pulse profile to be generated during the therapy session isselected from the therapy pulse profile data 708 at step 1106 and atstep 1108, the therapy pulse profile is configured as desired based uponthe patient's age, injury, or other patient data 702 and any of thepatients NNS assessment data 704. The orofacial stimulator appliance 108is calibrated at step 1110, while the patient is positioned to encouragea rooting response to the orofacial stimulator appliance at step 1112.At step 1114, the therapy session is started, while the orofacialstimulator appliance is contacted with the patient's lips and mouth atstep 1116. In other aspects, the orofacial stimulator appliance 108 isinserted into the patient's mouth at step 1116. Similarly, in otheraspects, the steps 1114 and 1116 may be reversed. During the therapysession, the user may attempt to hold the patient as still as possible.

Once the therapy session is completed, the orofacial stimulatorappliance 108 is removed from the patient at step 1118. The user mayprovide summary remarks regarding the therapy session at step 1120 usingthe GUI input form 1274 generated by the post-therapy review module 606.After the therapy session, the user may initiate another therapy sessionfor the same patient or a different patient. Alternatively, the user mayinstead exit the NNS application 204.

Exemplary Methods of Use by a Medical Professional to Treat anIndividual with Impaired Neural Function

An exemplary method of using the therapeutic stimulus system 100 by amedical professional to treat a patient having impaired neural functionincludes an initial step of powering on the various components of theNNS system, including the pulse generation system 106 and the computingdevice 102. Optionally, the user may verify that a back-up power supply,such as a battery, is properly connected, such that the use of the NNSsystem will not be compromised by a loss of power.

After accessing the computing device and executing the NNS application204, the user logs in to the NNS application, by selecting theirusername from a displayed list of approved usernames. The user theninputs their password to log in to the NNS application. The medicalprofessional may now access the records of an existing patient toperform an assessment or provide therapeutic stimulation. Alternately,the user may enter and save data regarding a new patient to the NNSsystem.

To begin an assessment session, the user selects the patient's name in adisplayed “Active Patient List”. Next, the user selects “Assessment” toenter the assessment mode of the NNS application. The user then selectsa “Start New Assessment” control button and enters data into a displayed“Configuring Assessment” user interface. The user may enter, forexample, the estimated minutes required for assessment and the color ortype of pacifier to be used. After entering the data, the user continuesand may select a displayed “Calibrate” control button, or depress theswitch on the handpiece to automatically calibrate the system.

The user moves and positions the therapeutic stimulus system near thepatient and encourages the patient to take the pacifier into theirmouth. To begin the assessment session, the user presses the hand-piecebutton or selects a displayed “Start” control button, and gently placesthe pacifier in the infant's mouth. During the session, the user maypress the hand-piece button or a displayed “Pause/Resume” control buttonto pause the session. The assessment session will automatically stopwhen the designated time is complete, and the user may then gentlyremove the pacifier from infant's mouth. To complete the assessmentsession, the user touches a “Close” control button, enters additionaldata in the displayed “Session summary” display, and finally concludesthe session by selecting a “Done” control button.

To begin therapy session, the user powers on the system and executes theNNS application, similar to the steps of performing an assessmentsession. The user selects the patient's name in the displayed “ActivePatient List”. Next, the user selects “Therapy” to enter the therapymode of the NNS application. The user then selects a “Start New Therapy”control button and enters data into a displayed “Configuring Therapy”user interface. The user may select the type of therapy most appropriatefor the patient. For example, the user may select a “Pre Oral Feed”control button to perform for a three minute therapeutic session priorto a patient's oral feeding. Conversely, the user may select “GavageFeed” control button to provide therapeutic stimulus in combination witha non-oral feeding. After selecting the therapy type, the user continuesand may select a displayed “Calibrate” control button, or depress theswitch on the handpiece to automatically calibrate the system.

The user moves and positions the therapeutic stimulus system near thepatient and encourages the patient to take the pacifier into theirmouth. To begin the therapy session, the user presses the hand-piecebutton or selects a displayed “Start” control button, and gently placesthe pacifier in the infant's mouth. The user is reminded to hold thehandpiece as still as possible during the therapy session. The therapysession will automatically stop when the designated time or therapyprotocol is complete, and the user may then gently remove the pacifierfrom infant's mouth. To complete the assessment session, the usertouches a “Close” control button, enters additional data in thedisplayed “Session summary” display, and finally concludes the sessionby selecting a “Done” control button.

Exemplary Methods of Use by a Medical Professional to Treat an Infant

An exemplary method of using the therapeutic stimulus system 100 by amedical professional to treat an infant having a deficient NNS patternincludes an initial step of powering on the various components of theNNS system, including the pulse generation system 106 and the computingdevice 102. Optionally, the user may verify that a back-up power supply,such as a battery, is properly connected, such that the use of the NNSsystem will not be compromised by a loss of power.

After accessing the computing device and executing the NNS application204, the user logs in to the NNS application, by selecting theirusername from a displayed list of approved usernames. The user theninputs their password to log in to the NNS application. The medicalprofessional may now access the records of an existing patient toperform an assessment or provide therapeutic stimulation. Alternately,the user may enter and save data regarding a new patient to the NNSsystem.

To begin an assessment session, the user selects the patient's name in adisplayed “Active Patient List”. Next, the user selects “Assessment” toenter the assessment mode of the NNS application. The user then selectsa “Start New Assessment” control button and enters data into a displayed“Configuring Assessment” user interface. The user may enter, forexample, the estimated minutes required for assessment and the color ortype of pacifier to be used. After entering the data, the user continuesand may select a displayed “Calibrate” control button, or depress theswitch on the handpiece to automatically calibrate the system.

The user positions the swaddled infant in a relaxed position or afeeding position and encourages a rooting response to pacifier. To beingthe assessment session, the user presses the hand-piece button orselects a displayed “Start” control button, and gently places thepacifier in the infant's mouth. During the session, the user may pressthe hand-piece button or a displayed “Pause/Resume” control button topause the session. The assessment session will automatically stop whenthe designated time is complete, and the user may then gently remove thepacifier from infant's mouth. To complete the assessment session, theuser touches a “Close” control button, enters additional data in thedisplayed “Session summary” display, and finally concludes the sessionby selecting a “Done” control button.

To begin therapy session, the user powers on the system and executes theNNS application, similar to the steps of performing an assessmentsession. The user selects the patient's name in the displayed “ActivePatient List”. Next, the user selects “Therapy” to enter the therapymode of the NNS application. The user then selects a “Start New Therapy”control button and enters data into a displayed “Configuring Therapy”user interface. The user may select the type of therapy most appropriatefor the patient. For example, the user may select a “Pre Oral Feed”control button to perform for a three minute therapeutic session priorto a patient's oral feeding. Conversely, the user may select “GavageFeed” control button to provide therapeutic stimulus in combination witha non-oral feeding. After selecting the therapy type, the user continuesand may select a displayed “Calibrate” control button, or depress theswitch on the handpiece to automatically calibrate the system.

The user positions the swaddled infant in a relaxed position or afeeding position, as necessary, and encourages a rooting response topacifier. To being the therapy session, the user presses the hand-piecebutton or selects a displayed “Start” control button, and gently placesthe pacifier in the infant's mouth. The user is reminded to hold thehandpiece as still as possible during the therapy session. The therapysession will automatically stop when the designated time or therapyprotocol is complete, and the user may then gently remove the pacifierfrom infant's mouth. To complete the assessment session, the usertouches a “Close” control button, enters additional data in thedisplayed “Session summary” display, and finally concludes the sessionby selecting a “Done” control button.

The method may also be performed on patient's other infants. The methodis substantially the same; however the patient is clothed and positionedas appropriate for the patient's age, physical condition, or any otherfactor deemed relevant to the patient's care.

It will be appreciated that the device and method of the presentinvention are capable of being incorporated in the form of a variety ofembodiments, only a few of which have been illustrated and describedabove. The invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive and the scope of the invention is, thereforeindicated by the appended claims rather than by the foregoingdescription. All changes, which come within the meaning and range ofequivalency of the claims, are to be embraced within their scope.

What is claimed is:
 1. A method for stimulating a suck central patterngenerator and a trigeminal nerve in a brain of a human subject, suchstimulation influencing brain response or brain development includingrepair of the brain, control of respiration, control of a non-nutritivesuck pattern, mastication, and combinations thereof, the methodcomprising: contacting the human subject with an appliance to stimulateone or more nerve ending near the subject's mouth, including the facialregion proximal to at least one lip and a tongue; and, actuating theappliance in response to a signal to generate a mechanical transfer ofenergy in at least one burst as an impulse sufficient to be recognizedas a tactile stimulus by the subject's suck central pattern generator;wherein each burst comprises at least two square wave pulses of the sameamplitude with the pulse period increasing with each successive pulse toform a decelerating pulse train sequence; and, wherein the square wavepulses range in frequency between 1.5 Hz and 5 Hz.
 2. The method ofclaim 1, wherein at least six bursts in succession are contacted withthe subject for at least two minutes at least twice a day.
 3. The methodof claim 1 wherein the square wave pulse displaces a surface of theappliance between about 150 microns and 300 microns for between 20milliseconds and 50 milliseconds.
 4. The method of claim 3, wherein thesurface is displaced between about 260 microns and 300 microns.
 5. Themethod of claim 3, wherein at least six bursts in succession arecontacted with the subject for at least two minutes at least twice aday.
 6. The method of claim 1 further comprising: stimulating anolfactory or auditory region.
 7. The method of claim 1 wherein theappliance comprises a textured nipple, a pneumatic pulse generator, anda baglet, and wherein the appliance is in communication with a softwaresystem.
 8. The method of claim 1 wherein the appliance comprises apiezoelectric system.
 9. The method of claim 1 wherein the applianceprojects sound waves to generate the square wave pulses.
 10. The methodof claim 1, wherein the tactile stimulus is above background activity ofthe subject and the signal is a high velocity signal.
 11. The method ofclaim 1 wherein the subject is an infant with a congenital heart defect,wherein the congenital heart defect prevents the infant from feedingefficiently.
 12. The method of claim 1 wherein the subject is a strokepatient, wherein the patient is unable to receive nourishmentefficiently.
 13. A system for stimulating a central pattern generatorand a trigeminal nerve in a brain of a human subject, such stimulationinfluencing brain response or brain development including repair of thebrain, control of respiration, control of a non-nutritive suck pattern,mastication, and combinations thereof, the system comprising: anorofacial stimulator appliance that, when actuated in response to asignal, generates a mechanical transfer of energy in at least one burstas an impulse sufficient to be recognized as a tactile stimulus by thesubject's central pattern generator; wherein each burst comprises atleast two square wave pulses of the same amplitude with the pulse periodincreasing with each successive pulse to form a decelerating pulse trainsequence; and, wherein the square wave pulses range in frequency between1.5 Hz and 5 Hz and are contacted with the subject for at least twominutes each day, at least twice a day for a minimum of five successivedays.
 14. The system of claim 13, wherein the orofacial stimulatorappliance is in communication with a control application executable at aprocessor.
 15. The system of claim 13, further comprising a pneumaticpulse generator that includes a PID controller and a pneumatic pulsegenerator, wherein the PID controller is an analog or real-timecontroller.
 16. The system of claim 15, wherein the PID controller is aCompactRIO controller.
 17. The system of claim 15, wherein the pneumaticpulse generator comprises a linear motor further comprising a positionfeedback sensor and a pressure feedback sensor.
 18. The system of claim15, wherein the pneumatic pulse generator is a position controlledpneumatic piston and cylinder having a position feedback sensor and apressure feedback sensor, the pneumatic piston and cylinder beingresponsive to real-time input.
 19. The system of claim 13, wherein eachof the two or more square wave pulses comprises a harmonic of a basefrequency.
 20. The system of claim 13, wherein the harmonic for the twoor more square wave pulses vary in frequency.
 21. The system of claim13, wherein the harmonic for the two or more pressure pulses areidentical in frequency.
 22. The system of claim 13, wherein each of thetwo or more pressure pulses have a damped harmonic profile.
 23. Thesystem of claim 22, wherein the damped harmonic oscillator profile ofthe two or more pressure pulses has a Q factor greater than or equal to½.
 24. The system of claim 13, wherein the signal further comprises arest period yielding no displacement to the orofacial stimulatorappliance.
 25. The system of claim 13, wherein the processing devicefurther comprises: a display device; and, an input device.
 26. Thesystem of claim 13, wherein the orofacial stimulator appliance furthercomprises: a handpiece; a receiver tube; a receiver tube insert; and, apacifier.
 27. The system of claim 26, wherein the handpiece comprises apush-button switch in communication with a control application.
 28. Asystem for stimulating a central pattern generator and a trigeminalnerve in a brain of a human subject, such stimulation influencing brainresponse or brain development including repair of the brain, control ofrespiration, control of a non-nutritive suck pattern, mastication, andcombinations thereof, the system comprising: a control system forgenerating a pressure pulse signal at a pneumatic pulse generatorassembly; the pneumatic pulse generator assembly comprising: a linearmotor mechanically engaged to a piston of a pneumatic piston andcylinder, wherein the linear motor exerts force on the piston; thepneumatic piston and cylinder to provide a pneumatic pressure pulse tothe pliable pacifier through a pneumatic airline in response to theforce applied to the piston; and, at least one feedback sensor toprovide position feedback data and pressure feedback data of the linearmotor; an orofacial stimulator appliance comprising: the pacifier influid engagement with a receiver tube, the receiver tube in fluidcommunication with the pneumatic airline to provide the pneumaticpressure pulse from the pneumatic piston and cylinder to the pacifiersurface; and, a removable receiver tube insert received in the receivertube to limit a total volume of air in receiver tube; wherein pressurepulse is a burst comprising at least two square wave pulses of the sameamplitude with the pulse period increasing with each successive pulse toform a decelerating pulse train sequence; and, wherein the square wavepulses range in frequency between 1.5 Hz and 5 Hz and are contacted withthe subject for at least two minutes each day, at least twice a day fora minimum of five successive days.
 29. The system of claim 28, wherein astimulus pattern of the pressure pulses cause the pacifier surface tohave a net displacement of at least 260 μm.
 30. The system of claim 28,wherein a first diameter of the pacifier during the first pressure pulseis at least 260 μm greater than a second diameter of the pacifier duringthe second pressure pulse.
 31. The system of claim 29, wherein thestimulus pattern comprises: six pressure pulses separated by intervalperiods of increasing duration, the six pressure pulses alternatingbetween the positive displacement of the pacifier surface and thenegative displacement of the pacifier surface.
 32. The system of claim29, wherein the stimulus pattern comprises: six pressure pulsesseparated by interval periods of increasing duration, the six pressurepulses causing the positive displacement of the pacifier surface. 33.The system of claim 29, wherein the stimulus pattern comprises: sixpressure pulses separated by interval periods of increasing duration,the six pressure pulses causing the negative displacement of thepacifier surface.
 34. The system of claim 31, wherein a first intervalafter the first pressure pulse has a duration of 510 milliseconds, asecond interval after the second pressure pulse has a duration of 526milliseconds, a third interval after a third pressure pulse has aduration of 551 milliseconds, a fourth interval after a fourth pressurepulse has a duration of 580 milliseconds, and a fifth interval after afifth pressure pulse has duration of 626 milliseconds.
 35. The system ofclaim 31, wherein the six pressure pulses are followed by a rest periodyielding no displacement of the pacifier surface.
 36. The system ofclaim 33, wherein the stimulus pattern is repeated at least once. 37.The system of claim 28, wherein the orofacial stimulator appliancefurther comprises: a function switch to alternate between a therapy modeand an assessment mode, wherein the stimulus pattern is applied in thetherapy mode and the non-nutritive suck pattern of the patient isassessed during the assessment mode; an activation switch; and a secondpressure sensor.
 38. The system of claim 28, wherein the receiver insertreduces the total volume of air in the receiver tube from 5.0 mL to 1.0mL.
 39. The system of claim 28 further comprising a laser micrometer,wherein the laser micrometer measures a frequency and the amplitude ofthe square wave pulses.
 40. A method for stimulating a central patterngenerator and a trigeminal nerve in an adult human brain of an adultsubject, such stimulation influencing brain response or braindevelopment including repair of the brain, control of respiration,control of a non-nutritive suck pattern, mastication, and combinationsthereof, the method comprising: contacting the adult subject with anappliance to stimulate one or more nerve ending near the subject'smouth, including the facial region proximal to at least one lip and atongue; and, actuating the appliance in response to a signal to generatea mechanical transfer of energy in at least one burst as an impulsesufficient to be recognized as a tactile stimulus by the subject'scentral pattern generator; wherein each burst comprises at least twosquare wave pulses of the same amplitude with the pulse periodincreasing with each successive pulse to form a decelerating pulse trainsequence; and, wherein the square wave pulses range in frequency between1.5 Hz and 5 Hz.
 41. The method of claim 38 wherein the burst displacesa surface of the appliance between about 260 microns and 300 microns forbetween 20 milliseconds and 50 milliseconds, and wherein at least sixbursts in succession are contacted with the adult subject for at leasttwo minutes, at least twice a day.
 42. The method of claim 38 wherein amotion induced by the burst has an amplitude ranging between 260 micronsand 300 microns.
 43. The method of claim 38 wherein the pulses in theburst decelerate.
 44. The method of claim 38 wherein the adult iscontacted with a burst that comprises six pulses.
 45. The method ofclaim 43 wherein the decelerating pulse train has period intervals of510, 526, 551, 580, and 626 ms.
 46. The method of claim 42 wherein thepulses have frequencies of 1.7 Hz, 5.5 Hz, 9.0 Hz, 12, 5 Hz, and 16.5Hz.
 47. A method of using a square wave to stimulate the central patterngenerator nerve, the method comprising: contacting a human subject withan appliance to stimulate one or more nerve ending near the subject'smouth, including the facial region proximal to at least one lip and atongue; and, actuating the appliance in response to a signal to generatea mechanical transfer of energy in at least one burst as an impulsesufficient to be recognized as a tactile stimulus by the subject'scentral pattern generator; wherein each burst comprises at least twosquare wave pulses of the same amplitude with the pulse periodincreasing with each successive pulse to form a decelerating pulse trainsequence; wherein the square wave pulses range in frequency between 1.5Hz and 5 Hz; and, wherein at least six bursts in succession arecontacted with the subject for at least two minutes, at least twice aday.